1. Field of the Invention
The present invention relates to a computerized system for conducting medical studies.
2. Description of the Prior Art
Medical studies are usually conducted with the aid of patients who are in the care of medical practices or clinics. By means of such medical studies, the success of specific therapeutic measures and the like can be representatively evaluated by empirical inquiries. The medical studies in the clinics or medical practices are conducted on specific patients who satisfy prescribed inclusion criteria for the medical studies. The results of the medical studies are evaluated by study supervisors.
Medical studies, particularly multicenter studies, require a high administration and coordination outlay. Numerous problems must be overcome in conducting medical studies. The clinics and medical practices which participate in the medical study must be informed about the study to be conducted and the corresponding inclusion, or exclusion, criteria. Depending on these criteria, patients who are eligible for participation in the corresponding medical study must be identified or selected. The eligible patients must then be registered with the study supervisors and assigned to appropriate study groups. Finally, the data of the participating patients that are amassed in the course of a medical study must be correctly acquired and communicated to the study supervisors.
Heretofore, a majority of the administration work in the conduct of medical studies has occurred by human activity. A physician usually checks whether one of his or her patients is eligible for a specific medical study and reports this to the study supervisors, possibly via one or more intermediaries, the patient data usually being transmitted on paper. The study supervisors assign the patients to an appropriate group, create study protocols, monitor the prompt entry of study data and request missing data. The communication between the study supervisors and the medical practice or the participating patient usually occurs via conventional mail, i.e. by means of written correspondence.
It is obvious that this procedure demands a high administrative outlay and is time-intensive and expensive. In particular, the administrative outlay rises rapidly with the number of participating patients or participating clinics/medical practices.
Although proposals exist for an information system for conducting medical studies over the Internet or for supporting study supervisors by the use of computers, these are not sufficiently specific to provide a truly realizable tool for conducting a computer-supported study (cf. “Einsatz von Internet-Diensten und Werkzeugen zur Unterstützung der Dateneingabe und das Monitorings multizentrischer klinischer Studien”, P. Wübbelt et al 42. Jahrestagung der GMDS, Ulm, September 1997, MMV Medizin Verlag München or “Ein WWW-basiertes Informations—und Kommunikationssystem für multizentrische medizinische Studien”, A. Selz et al, Vortrag auf der 42. Jahrestagung der GMDS, Ulm, 1997).